3-dose COVID vaccine is safe and effective for children under 5 – NBC Chicago

Three doses of Pfizer’s COVID-19 vaccine provide strong protection for children under 5, the company announced Monday. Pfizer plans to provide the data to US regulators later this week to allow little ones to get vaccinated.

The news comes after months of anxious waiting by desperate parents to get their babies, toddlers and preschoolers vaccinated, especially as COVID-19 cases rise again. The 18 million children under age 5 are the only group in the United States not yet eligible for the COVID-19 vaccination.

The Food and Drug Administration has begun evaluating data from rival Moderna, which hopes to start offering two injections for children by the summer.

Pfizer had a harder time understanding his approach. He aims to give toddlers an even lower dose – just a tenth of the amount adults get – but found during his trial that two shots didn’t seem strong enough for preschoolers. The researchers therefore gave a third injection to more than 1,600 youngsters – aged between 6 months and 4 years – during the winter surge of the omicron variant.

In a press release, Pfizer and partner BioNTech said the extra dose did the trick, boosting anti-virus antibody levels enough to meet FDA criteria for safe emergency use of the vaccine. of security.

Preliminary data suggests the three-dose series is 80% effective in preventing symptomatic COVID-19, the companies said, but they cautioned that the calculation is based on just 10 cases diagnosed among study participants at the end of April. Study rules state that at least 21 cases are needed to formally determine efficacy, and Pfizer has promised an update as soon as more data becomes available.

The companies had already submitted data on the first two doses to the FDA, and BioNTech CEO Dr. Ugur Sahin said final data from the third shot would be submitted this week.

“The study suggests that a low dose of 3 micrograms of our vaccine, carefully selected based on safety data, provides young children with a high level of protection against recent strains of COVID-19,” he said. he said in a statement.

Pfizer’s finding that toddlers produce similar antibodies at levels that protect young adults is encouraging, said Dr. Jesse Goodman of Georgetown University, former FDA vaccine chief.

If the FDA confirms the data, the vaccine could “be an important tool in helping parents protect their children,” Goodman said. But he warned that tracking the duration of protection, especially against serious illnesses, is essential.

Moderna has submitted data to the Food and Drug Administration that it hopes will prove that two low-dose injections can protect children under the age of 6.

And after? FDA Vaccine Chief Dr. Peter Marks has pledged the agency “will act quickly without sacrificing our standards” in assessing Pfizer and Moderna’s early doses.

Moderna seeks to be the first to vaccinate the little ones. He submitted data to the FDA indicating that toddlers develop high levels of anti-virus antibodies after two injections containing a quarter of the adult dose. The Moderna study found efficacy against symptomatic COVID-19 to be 40% to 50% during the omicron surge, much like adults who received only two doses of the vaccine.

Complicating Moderna’s progress, the FDA has so far licensed its vaccine for use only in adults. Other countries allow it for distribution as young as 6 years old, and the company is also seeking FDA clearance for teens and elementary-aged children.

The FDA had set tentative dates in June for its scientific advisers to publicly debate the data from Moderna and Pfizer. The latest goal: June 14 to consider whether to allow the Moderna vaccine for older children and June 15 to debate vaccinations for toddlers under 5, from either or both companies depending on the status of the requests.

If either vaccine is licensed for younger children, the Centers for Disease Control and Prevention should recommend whether all children under age 5 should receive them or only those at high risk.

Although COVID-19 is generally not as dangerous for young people as it is for adults, some children become seriously ill or even die. And the omicron variant has particularly affected children, with those under 5 being hospitalized at higher rates than at the height of the previous delta surge.

It is not known how many requests there will be to vaccinate the youngest children. Pfizer vaccines for ages 5 to 11 opened in November, but only about 30% of that age group received the recommended initial two doses. Last week, U.S. health officials said elementary-aged children should get a booster shot like everyone 12 and older is supposed to get, for the best protection against the latest coronavirus variants.

The center’s director, Dr. Rochelle Walensky, adopted a panel’s recommendation on Thursday.

NBC Chicago

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